A Comparison of Fortiva and Strattice Tissue Matrices in Complex, Ventral Hernia Repair

A Randomized, Prospective Study Comparing Fortiva™ Porcine Dermis vs. Strattice™ Reconstructive Tissue Matrix in Patients Undergoing Complex Open Primary Ventral Hernia Repair

The objective of this study is to compare the effectiveness of Fortiva Porcine Dermis versus Strattice Reconstructive Tissue Matrix for the underlay reinforcement of complex ventral hernia repair and assess post-operative complication rates, long term hernia recurrence rates.

Study Overview

• Status: Completed
• Conditions: Ventral Hernia
• Intervention / Treatment: Device: Fortiva™ Porcine Dermis; Device: Strattice™ Reconstructive Tissue Matrix

Detailed Description

This is a randomized, prospective, double-blinded study evaluating the efficacy of Fortiva Porcine Dermis versus Strattice Reconstructive Tissue Matrix in 120 patients with large complex abdominal wall ventral hernias undergoing single stage repair. The patient will be blinded to treatment as well as an independent qualified evaluator to confirm evidence of reoccurrence. This post-market study compares two FDA cleared biologic hernia materials. Fortiva™ porcine dermis, processed by RTI Surgical, Inc., a non-cross linked porcine dermis will be compared to Strattice™ Reconstructive Tissue Matrix by Life Cell, a non-cross linked porcine dermis for reinforcement during the single stage open reconstruction of abdominal wall defects. The primary outcome will be hernia recurrence at 1 year. Outcomes will be evaluated at 6 weeks, 3 months, 6 months and 12 months and 24 months.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age or greater
• Have a BMI < or equal to 40
• Have a pre-operative estimated hernia defect of 200 cm2 OR multiple hernia defects whose combined area is ≥ an estimated 200 cm2. Patients whose defects do NOT meet or exceed 200 cm2 intra-operatively will be withdrawn from the study and will be considered an intra-operative screen failure
• Have no contraindications to the test material (s)
• Have a life expectancy greater than 1 year in the opinion of the Investigator
• Able to provide informed consent
• Able and willing to return for scheduled study visits over 2 years post-operatively (following research related surgery)

Exclusion Criteria:

• < 18 years of age
• Subject is determined to have an American Society of Anesthesiologists'(ASA) physical class of 4, 5, or 6
• Have a BMI >40
• Have a hernia estimated to be <200 cm2
• Have abdominal loss of domain such that the operation would be impractical or would adversely affect respiratory or cardiovascular function to an unacceptable degree in the opinion of the investigator
• Inability to close the fascia primarily without abdominal wall mobilization or component separation
• Participation in an investigational drug or device study that would impact the safety or scientific integrity of this study (in the opinion of the Investigator and with the approval of the Sponsor) within the past 6 weeks prior to enrollment into this trial
• Have active necrotizing fasciitis or any other known active local or systemic infection
• Have a known collagen metabolism disorder or any medical condition that could interfere with normal tissue healing process as determined by the Investigator
• Have a known active malignancy present and/or had chemotherapy 12 weeks prior to screening or planned chemotherapy within 12 weeks of enrollment with exception of BCC or SCC
• Have known moderate to severe cirrhosis which in the opinion of the Investigator would impact the outcome of this trial
• Have a life expectancy less than 1 year
• Be unable to participate in the informed consent process
• Be unable or unwilling to return for scheduled study visits over the 2 year post-operative assessment period
• Received high dose steroids (>/=100mg of prednisone) within the past 6 weeks
• Known tobacco use within the past 6 weeks or positive serum cotinine test at time of admission
• Uncontrolled diabetes (i.e. known HbA1C value > 7% within the last 6 weeks)
• History of drug addiction (recreational drugs, prescription drugs or alcohol) that in the Investigator's opinion may interfere with protocol assessments and/or the subject's ability to complete the required follow up
• Pregnancy and/or breastfeeding
• Enterocutaneous fistula
• Ventral hernia repairs involving active infection
• Inability to obtain primary fascial closure (Intra-operatively)
• Planned use of external VAC dressing intra-operatively

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fortiva™ Porcine Dermis; Fortiva Porcine Dermis implantation during repair of complex ventral hernia	Device: Fortiva™ Porcine Dermis; Fortiva Porcine Dermis implantation during repair of complex ventral hernia
Active Comparator: Strattice™ Reconstructive Tissue Matrix; Strattice tissue matrix implanted during repair of complex ventral hernia	Device: Strattice™ Reconstructive Tissue Matrix; Strattice tissue matrix implanted during repair of complex ventral hernia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Proportion of Patients Who Experience a True Hernia Recurrence	True hernia recurrence as diagnosed by physical exam or CT scan	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36 MCS	SF-36 mental component summary scale ranges from 0-100. Higher score indicates better self reported health.	3 months
Pain Measured Using the Visual Analog Scale for Pain	Visual analog scale measures extremes of pain on a scale from 0-10. 0 is no pain and 10 is worst pain	3 months
True Recurrence at 24 Months		24 months
Time to Discharge	Time is from date of procedure to date of each patient discharge. Mean of each group is provided	Discharge

Collaborators and Investigators

• Sponsor: RTI Surgical
• Investigators: Principal Investigator: Grant Bochicchio, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2015
• Primary Completion (Actual): September 19, 2023
• Study Completion (Actual): September 19, 2023

Study Registration Dates

• First Submitted: October 22, 2015
• First Submitted That Met QC Criteria: October 23, 2015
• First Posted (Estimated): October 27, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: RTI-2015-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO